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1.
The Lancet Regional Health - Americas ; 16:100366, 2022.
Article in English | ScienceDirect | ID: covidwho-2042000

ABSTRACT

Summary Background COVID-19 vaccines have proven safe and efficacious in reducing severe illness and death. Cuban protein subunit vaccine Abdala has shown safety, tolerability and efficacy (92·3% [95% CI: 85·7‒95·8]) against SARS-CoV-2 in clinical trials. This study aimed to estimate Abdala's real-world vaccine effectiveness (VE). Methods This retrospective cohort study in Havana analyzed Cuban Ministry of Public Health databases (May 12-August 31, 2021) to assess VE in preventing severe illness and death from COVID-19 (primary outcomes). Cox models accounting for time-varying vaccination status and adjusting by demographics were used to estimate hazard ratios. A subgroup analysis by age group and a sensitivity analysis including a subgroup of tested persons (qRT-PCR) were conducted. Daily cases and deaths were modelled accounting for different VE. Findings The study included 1 355 638 persons (Mean age: 49·5 years [SD: 18·2];704 932 female [52·0%];ethnicity data unavailable): 1 324 vaccinated (partially/fully) and 31 433 unvaccinated. Estimated VE against severe illness was 93·3% (95% CI: 92·1-94·3) in partially- vaccinated and 98·2% (95% CI: 97·9-98·5) in fully-vaccinated and against death was 94·1% (95% CI: 92·5-95·4) in partially-vaccinated and 98·7% (95% CI: 98·3-99·0) in fully-vaccinated. VE exceeded 92·0% in all age groups. Daily cases and deaths during the study period corresponded to a VE above 90%, as predicted by models. Interpretation The Cuban Abdala protein subunit vaccine was highly effective in preventing severe illness and death from COVID-19 under real-life conditions. Funding Cuban Ministry of Public Health. Genetic Engineering and Biotechnology Centre.

2.
International Journal of Infectious Diseases ; 2022.
Article in English | ScienceDirect | ID: covidwho-2041809

ABSTRACT

Objectives : To compare mRNA-based (mRNA) and adenovirus-vectored vaccines (ADVV) with inactivated virus vaccines (IVV) using real-world aggregate data. Methods : We performed longitudinal analyses of publicly accessible epidemiological, clinical, virological, vaccine-related and other public health data from 41 eligible countries during the first half of 2021. The relationships between vaccination coverage and clinical outcomes were analyzed using repeated measures correlation analyses and mixed effects modeling to adjust for potential mediating and confounding factors. Results : Countries that used mRNA and/or ADVV (n=31) vs. IVV, among other vaccine types (n=10), had different distributions of age (42·4 vs. 33·9 years, respectively;P=0·0006), gross domestic product/capita ($38,606 vs. $20,422, respectively;P<0·0001) and population sizes (8,655,541 vs. 5,139,162, respectively;P=0·36). After adjustment for country differences, stringency of nonpharmaceutical interventions and dominant SARS-CoV-2 variant types, populations that received mRNA and/or ADVV had significantly lower rates of cases and deaths over time (P<0·001 for each analysis). Populations vaccinated with IVV, among others, had significantly higher rates of cases and deaths over time (P<0·05 for each analysis). Conclusions : Real-world effectiveness of IVV may be inferior to mRNA and/or ADVV, and prospective comparative studies are needed to critically evaluate the role of IVV in the context of contemporary SARS-CoV-2 variants.

3.
Annals of Oncology ; 33:S635, 2022.
Article in English | EMBASE | ID: covidwho-2041521

ABSTRACT

Background: A subgroup of triple negative breast cancer (TNBC) expresses the androgen receptor (AR). In this trial we evaluated the efficacy and tolerability of the AR inhibitor darolutamide (D) or capecitabine (C) in patients (pts) with advanced AR-positive TNBC (NCT03383679). Methods: Pts with centrally reviewed AR-positive (≥ 10% by immunohistochemistry) TNBC treated with up to one line of chemotherapy for advanced disease were eligible. They were randomized in a 2:1 ratio to receive D 600 mg twice daily or C 1000 mg/m2 twice daily 2-weeks on/ 1-week off, until progression or unacceptable toxicity. Primary endpoint was clinical benefit rate (CBR) at 16 weeks and was assessed in the eligible population and in the sensitivity analysis population (pts with delayed tumour assessment performed in the context of COVID pandemic). Main secondary endpoints included objective response rate, overall survival, progression-free survival (PFS) and safety. Results: A total of 254 pts from 45 centres were screened;94 pts were randomized (61 in D arm, 33 in C arm) from April 2018 to July 2021. A clinical benefit was observed in D arm in 13 of 53 evaluable pts (CBR at 16 weeks 24.5%;95% CI: 12.9%-36.1%) including 2 PR and 1 CR and in C arm in 11 of 23 evaluable pts (CBR at 16 weeks 47.8%;95% CI: 27.4%-68.2%). In the sensitivity analysis, a clinical benefit was observed in D arm in 17 of 58 evaluable patients (CBR ≥ 16 weeks 29.3%;95% CI: 17.6%-41.0%) and in C arm in 19 of 32 evaluable patients (CBR ≥ 16 weeks 59.4%;95% CI: 42.3%-76.4%). 7 pts presented with drug-related serious adverse events: 3 in D arm and 4 in C arm. In D arm, asthenia (26.7%), nausea (25%) and ASAT increase (21.7%) were the most common adverse events, the majority being grade 1 or 2, similar to previous safety data. Median PFS were 1.8 months (CI 95% 1.7-3.1) and 3.6 months (1.8-9.1) in D arm and C arm respectively. Other secondary endpoints will be presented at the meeting. Conclusions: Despite not reaching the pre-specified CBR, darulotamide demonstrated clinical activity with significant benefit for a group of patients. A research program to identify predictive biomarkers of sensitivity is ongoing. Clinical trial identification: EudraCT: 2017-002284-18 NCT03383679. Legal entity responsible for the study: UNICANCER. Funding: BAYER. Disclosure: All authors have declared no conflicts of interest.

4.
Pharmaceutical Journal ; 308(7961), 2022.
Article in English | EMBASE | ID: covidwho-2041070
5.
Transplantation ; 106(8):44, 2022.
Article in English | EMBASE | ID: covidwho-2040915

ABSTRACT

Background: Liver transplant recipients have a poorer vaccine response than the general population. Real-life data on SARS-CoV-2 vaccination in liver transplant recipients are limited. The objective of this study was to evaluate the efficacy and safety of the vaccine and identify factors associated with vaccine response. Methods: This was a retrospective observational study of consecutive liver transplant recipients attending CHU De Montpellier. Data on the transplantation indication, immunosuppression, vaccine type, and serology 28 days after the last vaccine dose were collected. Serology below 30 BAU/ml (WHO units) defined non-responders, 30-260 BAU/ml low responders, and >260 BAU/ml responders. Results: 494 patients were included between 1 January and 15 March 2021. 366 (74%) patients were vaccinated: 280 with 3 doses, 63 with 2 doses, and 23 with 1 dose. Complete data were available for 234 patients. 164 (70.1%) patients were male, with a mean age of 59±12 years with a mean time to transplantation of 4.9±5.9 years. No serious adverse events were reported. Of 201 (85.9%) patients with complete vaccination and post-vaccination serology, 104 (51.7%) were responders, 45 (22.4%) poor responders, and 52 (25.9%) nonresponders. In multivariate analysis, factors associated with no or low response were vaccination with Vaxzevria alone (HR 6.8 [1.46- 31.67], p=0.046), mycophenolate mofetil (MMF) therapy (HR 2.1 [1.1-3.9], p=0.025), no previous SARS-CoV-2 infection prior to vaccination (HR 3.6 [1.025-12.89], p=0.046), and female gender (HR 2.4 [1.15-4.99], p=0.02). Conclusions: Only half of our patients were vaccine responders after three injections. MMF, female gender, and Vaxzevria vaccination were associated with a poorer response, while previous SARS-CoV-2 exposure was associated with a better response.

6.
Russian Journal of Infection & Immunity ; 12(4):688-700, 2022.
Article in Russian | Academic Search Complete | ID: covidwho-2040490

ABSTRACT

In the context of the global spread of the new coronavirus infection, studies aimed at investigating formation of anti-infectious and post-vaccination immunity are of special importance, which is necessary to prevent and reduce morbidity and mortality due to SARS-CoV-2 infection. Purpose: to assess anti-infectious immunity against SARSCoV-2 in various forms of the disease and development of post-vaccination humoral reactions in medical workers of the perinatal center. Materials and methods. A study of blood serum was carried out to assess SARS-CoV-2-specific IgM and IgG antibodies in 119 medical workers recovered after COVID-19, divided into groups based on the disease severity (mild, moderate and asymptomatic), as well as in 62 vaccinated employees, divided into groups according to age. Semi-quantitative measurement of virus-specific antibodies was carried out by ELISA with test systems “SARS-CoV2-IgG-ELISA-BEST” and “SARS-CoV-2-IgM-ELISA-BEST”. Statistical processing of the research results was carried out using Microsoft Excel 2010 and Statistica 6. Quantitative characteristics were presented as median (ME), lower and upper quartiles (LQ1-UQ3);qualitative parameters - as absolute value and relative number (%). Difference between groups was analyzed by using the χ2 test (qualitative) and the Mann–Whitney U-test (quantitative). Results. The results of the study showed that the majority of employees with a moderate-severe form of SARS-CoV-2 had a high level of IgG (PR - a positivity rate of more than 9.0 arbitrary units) 9 months after the disease compared to those who suffered from mild or asymptomatic (83.3% versus 25.8% and 13.3%, p < 0.017) infection. The duration of IgG circulation after former illness had no relation to its severity and patient age. The effectiveness of the primary vaccination “Sputnik V” and revaccination with “Sputnik Light” and “KoviVak” was 100% after inoculating the vaccine second component. The lowest level of antibodies after the first vaccination is recorded in persons over 60 years old (1.48 (1.12–3.25 versus PR = 8.48 (5.78–10.11) and 9.27 (5.84–10.31) arbitrary units, p < 0.017)), in comparison with young and middle-age subjects. The speed SARS-CoV-2 elimination of IgG at 6, 9 or more months after vaccination depends on relevant initial peak antibody concentration. Subjects who were initially vaccinated with the KoviVac vaccine, IgG was not detected 2 months after vaccination. The protective effect of “Sputnik V”, “Sputnik Light”, “KoviVac” after re-infection with SARS-CoV-2 averages 71.2%. Conclusion. Thus, the results obtained on assessing anti-infectious and post-vaccination immunity against SARS-CoV-2 emphasize the need for further studies on a larger patient cohort, especially in those with asymptomatic infection as well as the elderly subjects. (English) [ FROM AUTHOR] Ð’ условиях глобального распространения новой коронавирусной инфекции особую значимость приобретают исследования, направленные на изучение формирования противоинфекционного и поствакцинального иммунитета, что является необходимым для предотвращения и снижения заболеваемости и смертности от SARS-CoV-2. Цель: оценить противоинфекционный иммунитет к SARS-CoV-2 при различных формах заболевания и развитие поствакцинальных гуморальных реакций у медицинских работников перинатального центра. Материалы и методы. Проведено исследование сыворотки крови на определение специ фических антител IgM и IgG классов к SARS-CoV-2 у 119 медицинских работников, перенесших COVID-19 и разделенных на группы в зависимости от тяжести течения заболевания (легкое, умеренное и бессимптомное), а также у 62 сотрудников, прошедших вакцинацию и разделенных на группы в зависимости от возраста. Полуколичественное определение антител осуществляли методом ИФА с использованием тест-систем «SARS-CoV-2-IgG-ИФА-БЕСТ» и «SARS-CoV-2-IgÐœ-ИФА-БЕСТ». Статистическую обработку результатов иcследования проводили с использованием программ «Microsoft Excel 2010» и Statistica 6. Количественные признаки представляли в виде медианы (МЕ), нижнего и верхнего квартилей (LQ1–UQ3);качественные- в виде абсолютного значения и относительного числа (%). Различия между группами устанавливали при помощи критерия χ2 (качественные) и Манна–Уитни (Mann–Whitney U-test) - количественные. Результаты. Результаты исследования показали, что у большинства сотрудников со среднетяжелой формой SARS-CoV-2 регистрируется более высокий уровень IgG (КП - коэффициент позитивности более 9,0 у.е.) спустя 9 месяцев после заболевания, чем у тех, кто переболел в легкой или бессимптомной форме (83,3% против 25,8% и 13,3%, Ñ€ < 0,017). Длительность циркуляции IgG после перенесенного заболевания не зависит от степени тяжести и возраста. Эффективность первичной вакцинации «Спутник V» и ревакцинации «Спутник Лайт» и «КовиВак» составляет 100% после введения второго компонента. Наименьший уровень антителпосле первой вакцинации регистрируется у лиц старше 60 лет (1,48 (1,12–3,25) против КП = 8,48 (5,78–10,11) и 9,27 (5,84–10,31) у.е., Ñ€ < 0,017) в сравнении с молодым и средним возрастом. Скорость элиминация IgG к SARS-CoV-2 через 6, 9 и более месяцев после проведения вакцинации зависит от их нач °Ð»ÑŒÐ½Ð¾Ð¹ пиковой концентрации. У первично привитых вакциной «КовиВак» IgG через 2 месяца после вакцинации не определяются. Протективный эффект «Спутник V», «Спутник Лайт», «КовиВак» от повторного заражения новой коронавирусной инфекции в среднем составляет 71,2%. Заключение. Таким образом, полученны результаты по оценке противоинфекционного и поствакцинального иммунитета к SARS-CoV-2 подчеркивают необходимость проведения дальнейших исследований на большей когорте пациентов, в особенности у лиц с бессимптомным течением инфекции и пожилых людей. (Russian) [ FROM AUTHOR] Copyright of Russian Journal of Infection & Immunity is the property of National Electronic-Information Consortium and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

7.
BMC Med ; 20(1):312, 2022.
Article in English | PubMed | ID: covidwho-2038745

ABSTRACT

BACKGROUND: The results of a randomised trial showed the safety and efficacy of Gam-COVID-Vac against COVID-19. However, compared to other vaccines used across the globe, the real-world data on the effectiveness of Gam-COVID-Vac, especially against the disease caused by the Delta variant of concern, was limited. We aimed to assess the effectiveness of vaccination mainly conducted with Gam-COVID-Vac in St. Petersburg, Russia. METHODS: We designed a case-control study to assess the vaccine effectiveness (VE) against referral to hospital. Self-reported vaccination status was collected for individuals with confirmed SARS-CoV-2 infection who were referred for initial low-dose computed tomography (LDCT) triage in two outpatient centres in July 3-August 9, 2021, in St. Petersburg, Russia. We used logistic regression models to estimate the adjusted (for age, sex, and triage centre) VE for complete (14 days or more after the second dose) vaccination. We estimated the VE against referral for hospital admission, COVID-19-related lung injury assessed with LDCT, and decline in oxygen saturation. RESULTS: In the final analysis, 13,893 patients were included, 1291 (9.3%) patients met our criteria for complete vaccination status, and 495 (3.6%) were referred to hospital. In the primary analysis, the adjusted VE against referral to hospital was 81% (95% confidence interval: 68-88) for complete vaccination. The VE against referral to hospital was more pronounced in women (84%, 95% CI: 66-92) compared to men (76%, 95% CI: 51-88). Vaccine protective effect increased with increasing lung injury categories, from 54% (95% CI: 48-60) against any sign of lung injury to 76% (95% CI: 59-86) against more than 50% lung involvement. A sharp increase was observed in the probability of hospital admission with age for non-vaccinated patients in relation to an almost flat relationship for the completely vaccinated group. CONCLUSIONS: COVID-19 vaccination was effective against referral to hospital in patients with symptomatic SARS-CoV-2 infection in St. Petersburg, Russia. This protection is probably mediated through VE against lung injury associated with COVID-19.

8.
BMC Health Serv Res ; 22(1):1190, 2022.
Article in English | PubMed | ID: covidwho-2038740

ABSTRACT

BACKGROUND: Mass community testing for SARS-CoV-2 by lateral flow devices (LFDs) aims to reduce prevalence in the community. However its effectiveness as a public heath intervention is disputed. METHOD: Data from a mass testing pilot in the Borough of Merthyr Tydfil in late 2020 was used to model cases, hospitalisations, ICU admissions and deaths prevented. Further economic analysis with a healthcare perspective assessed cost-effectiveness in terms of healthcare costs avoided and QALYs gained. RESULTS: An initial conservative estimate of 360 (95% CI: 311-418) cases were prevented by the mass testing, representing a would-be reduction of 11% of all cases diagnosed in Merthyr Tydfil residents during the same period. Modelling healthcare burden estimates that 24 (16-36) hospitalizations, 5 (3-6) ICU admissions and 15 (11-20) deaths were prevented, representing 6.37%, 11.1% and 8.2%, respectively of the actual counts during the same period. A less conservative, best-case scenario predicts 2333 (1764-3115) cases prevented, representing 80% reduction in would-be cases. Cost -effectiveness analysis indicates 108 (80-143) QALYs gained, an incremental cost-effectiveness ratio of £2,143 (£860-£4,175) per QALY gained and net monetary benefit of £6.2 m (£4.5 m-£8.4 m). In the best-case scenario, this increases to £15.9 m (£12.3 m-£20.5 m). CONCLUSIONS: A non-negligible number of cases, hospitalisations and deaths were prevented by the mass testing pilot. Considering QALYs gained and healthcare costs avoided, the pilot was cost-effective. These findings suggest mass testing with LFDs in areas of high prevalence (> 2%) is likely to provide significant public health benefit. It is not yet clear whether similar benefits will be obtained in low prevalence settings or with vaccination rollout.

9.
BMC Public Health ; 22(1):1803, 2022.
Article in English | PubMed | ID: covidwho-2038718

ABSTRACT

BACKGROUND: Studies of mRNA and vector-based vaccines used in different countries report acceptable levels of effectiveness against SARS-CoV-2 infection caused by the Delta variants of SARS-CoV-2. No studies estimated vaccine effectiveness (VE) of Gam-COVID-Vac and other vaccines used in Russia against symptomatic infection with Delta variant. In this population-based case-control study, we aimed to estimate the effectiveness of the Russian COVID-19 vaccines against symptomatic SARS-CoV-2 during the recent outbreak caused by the Delta VOC in October 2021 in St. Petersburg, Russia. METHODS: Cases were symptomatic patients with confirmed SARS-CoV-2 (using polymerase chain reaction (PCR) test) referred to low-dose computed tomography (LDCT) triage in two outpatient centres between October 6 and 14, 2021 during the Delta variant outbreak. We recruited the controls during the representative survey of the seroprevalence study conducted during the same period in St. Petersburg using random digit dialling. In the primary analysis, we used logistic regression models to estimate the adjusted (age, sex, and history of confirmed COVID-19) VE against symptomatic SARS-CoV-2 resulted in a referral to triage centre for three vaccines used in Russia: Gam-COVID-Vac, EpiVacCorona, and CoviVac. RESULTS: We included 1,254 cases and 2,747 controls recruited between the 6th and 14th of October in the final analysis. VE was 56% (95% CI: 48 to 63) for Gam-COVID-Vac (Sputnik V), 49% (95% CI: 29 to 63) for 1-dose Gam-COVID-Vac (Sputnik V) or Sputnik Light, -58% (95% CI: -225 to 23) for EpiVacCorona and 40% (95% CI: 3 to 63) for CoviVac. Without adjustment for the history of confirmed COVID-19 VE for all vaccines was lower, except for one-dose Gam-COVID-Vac (Sputnik Light). The adjusted VE was slightly lower in women - 51% (95% CI: 39 to 60) than men - 65% (95% CI: 5 to 73). CONCLUSIONS: Our preliminary results show that in contrast to other Russian vaccines, Gam-COVID-Vac is effective against symptomatic SARS-CoV-2 infection caused by Delta VOC. Effectiveness is likely higher than the estimated 56% due to bias arising from high prevalence of the past COVID-19 in St. Petersburg.

10.
Open Forum Infect Dis ; 9(9):ofac449, 2022.
Article in English | EuropePMC | ID: covidwho-2037503

ABSTRACT

Background: Waning protection from 2 doses of coronavirus disease 2019 (COVID-19) vaccines led to third dose availability in multiple countries even before the emergence of the Omicron variant. Methods: We used the test-negative study design to estimate vaccine effectiveness (VE) against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, any symptomatic infection, and severe outcomes (COVID-19-related hospitalizations or death) by time since second dose of any combination of BNT162b2, mRNA-1273, and ChAdOx1 between January 11, and November 21, 2021, for subgroups based on patient and vaccine characteristics. Results: We included 261 360 test-positive cases (of any SARS-CoV-2 lineage) and 2 783 699 individuals as test-negative controls. VE of 2 mRNA vaccine doses decreased from 90% (95% CI, 90%-90%) 7-59 days after the second dose to 75% (95% CI, 72%-78%) after >/=240 days against infection, decreased from 94% (95% CI, 84%-95%) to 87% (95% CI, 85%-89%) against symptomatic infection, and remained stable (98% [95% CI, 97%-98%] to 98% [95% CI, 96%-99%]) against severe outcomes. Similar trends were seen with heterologous ChAdOx1 and mRNA vaccine schedules. VE estimates for dosing intervals <35 days were lower than for longer intervals (eg, VE of 2 mRNA vaccines against symptomatic infection at 120-179 days was 86% [95% CI, 85%-88%] for dosing intervals <35 days, 92% [95% CI, 91%-93%] for 35-55 days, and 91% [95% CI, 90%-92%] for >/=56 days), but when stratified by age group and subperiod, there were no differences between dosing intervals. Conclusions: Before the emergence of Omicron, VE of any 2-dose primary series, including heterologous schedules and varying dosing intervals, decreased over time against any infection and symptomatic infection but remained high against severe outcomes.

11.
Oncol Ther ; 2022.
Article in English | PubMed | ID: covidwho-2035466

ABSTRACT

Granulocyte colony-stimulating factor (G-CSF) biologics, such as pegfilgrastim, are a standard of care in supportive cancer treatment that are administered once per chemotherapy cycle to reduce the incidence of febrile neutropenia. The high cost of these biologics in the United States can be a limiting factor to accessing care;however, lower-cost pegfilgrastim biosimilars have been available for several years for patients requiring prophylaxis of febrile neutropenia. Different options for pegfilgrastim administration are also now available to accommodate specific patient preferences. As patients may want to minimize the risk of both neutropenia and SARS-CoV-2 infection, same-day administration is a pertinent option during the present COVID-19 pandemic. Therefore, individualized, patient-centered approaches and risk-management strategies should be considered when selecting the treatment and administration method for prophylaxis of febrile neutropenia. Three methods of administration would minimize hospital or clinic visits while also providing the prophylactic effect of G-CSF: same-day administration after chemotherapy, use of the US Food and Drug Administration-approved on-body injector delivering pegfilgrastim approximately 27 h after chemotherapy, or self-administration by the patient or caregiver > 24 h after chemotherapy. Choice of the specific administration option should be based on the patient's specific needs, while also considering mitigating factors, such as the economic burden associated with biologic medications and the risk of COVID-19. Pegfilgrastim biosimilars can minimize the additional financial burden on patients and the health care system during this pandemic and beyond.

12.
Clin Microbiol Infect ; 2022 Aug 02.
Article in English | MEDLINE | ID: covidwho-2035886

ABSTRACT

OBJECTIVES: To describe effectiveness of mRNA vaccines by comparing 2-dose (2D) and 3-dose (3D) healthcare worker (HCW) recipients in the setting of Omicron variant dominance. Performance of 2D and 3D vaccine series against SARS-CoV-2 variants and the clinical outcomes of HCWs may inform return-to-work guidance. METHODS: In a retrospective study from December 15, 2020 - January 15, 2022, SARS CoV-2 infections among HCWs at a large tertiary cancer center in New York City (NYC) were examined to estimate infection rates over the omicron period (aggregated positive tests/person-days) and 95% CIs in 2D and 3D mRNA vaccinated HCWs and were compared using rate ratios. We describe the clinical features of post-vaccine infections and impact of prior (pre-Omicron) COVID infection on vaccine effectiveness (VE). RESULTS: Among the 20,857 HCWs in our cohort, 20,660 completed the 2D series with an mRNA vaccine during our study period and 12,461 had received a third dose by January 15, 2022. The infection rate ratio for 2D vs. 3D vaccinated HCWs was 0.667 (95% CI 0.623, 0.713) for an estimated 3D VE of 33.2% compared to 2 doses only during the Omicron dominant period from 12/15/21- 1/15/22. Breakthrough (BT) Omicron infections after 3D + 14 days occurred in 1315 HCWs. Omicron infections were mild, with 16% of 3D and 11% 2D HCWs being asymptomatic. CONCLUSIONS: Study demonstrates improved vaccine-derived protection against COVID-19 infection in 3D vs. 2D mRNA vaccinees during the Omicron surge. The advantage of 3D vaccination was maintained irrespective of prior COVID-19 infection status.

13.
Journal of STEM Education : Innovations and Research ; 23(3):5-11, 2022.
Article in English | ProQuest Central | ID: covidwho-2034341

ABSTRACT

This study investigates the effect of the COVID-19 pandemic on teacher self-efficacy with delivering designbased learning to elementary students in online or blended settings. This study also identifies what resources and supports teachers need to engage elementary students in design-based learning in online or blended settings. The population for this study was elementary teachers teaching STEM content and included a sample of four elementary STEM teachers from rural and suburban communities. Each participating teacher completed a semi-structured interview consisting of queries targeting both research questions within the study. The results of the qualitative analysis revealed a temporary decrease in teachers'selfefficacy at the beginning of the shift to a virtual environment. A lack of student access to resources at home, the teachers'lack of control and support for the student in a synchronous manner, and a shift in priorities for STEM education contributed to the temporary decrease in the teachers'self-efficacy. To remediate this, teachers reported condensing activities and the Engineering Design Process. They cited fellow educator support, previous coursework, additional time, and access to teacher resources as supports that would be beneficial in the current environment.

14.
NeuroQuantology ; 20(10):4249-4257, 2022.
Article in English | EMBASE | ID: covidwho-2033479

ABSTRACT

Background: With the advent of the coronavirus pandemic, Higher Education Organizations (HEOs), including medical schools, started using online education to effectively teach, and evaluate students’ performances. An increasingly popular contemporary modality offered by the digital e-learning market is a Learning Management System (LMS). Aims and Objectives: The aim isto assess Moodle v. 3.9 as a tool to conduct online medical examinations. The objectives are: 1. To collect student feedback 2. To discuss technical aspects with Moodle experts 3. To implement necessary changes based on the feedback and discussion Material and Methods: A short-term longitudinal observational study was conducted at the Symbiosis Medical College for Women, Pune, India to collect feedback from 143 students with regards to their online exam experience with Moodle and the technical difficulties they faced were noted. In collaboration with software experts, certain technical changes pertaining to bandwidth requirements were implemented. Results: We observed that the students require extra time as compared to the online exam scenario for conversion of their answer sheets into PDFs, and this technical aspect needs to be considered while designing such exams. We also established the server bandwidth that is essential for an uninterrupted online exam experience at the institute level. Lastly, student feedback suggested that the online examination environment is perceived as more stressful, compared to its live counterpart. Conclusion: We conclude that cost-effectiveness, user-friendly interface, and a multitude of assessment-related features make Moodle an efficient tool for conducting online medical examinationsattheundergraduatelevel.

15.
NeuroQuantology ; 20(10):2908-2915, 2022.
Article in English | EMBASE | ID: covidwho-2033475

ABSTRACT

Background: A severe antibody-mediated inflammatory demyelinating disease of the central nervous system is neuromyelitis optica spectrum disorder (NMOSD). Azathioprine (AZA) and Rituximab (RTX) were used to treat NMO-SD patients though not FDA approved yet. Aim of the study: To compare the effectiveness and safety of rituximab treatment versus azathioprine in treating individuals with NMOSDs. Methods: Seventy four Egyptian individuals with NMOSDs in this retrospective observational study and collecting their medical records from multiple sclerosis (MS) clinics, Neurology Departments, El-Maadi Military Hospital, and Cairo University hospitals. Fourty four patients received either treatment over two year duration, Group 1 (rituximab group) consisted of 19 patients, while group 2 (azathioprine group) consisted of 25 patients. Their full medical history, general and neurological examination, MRI brain and spinal cord results, and laboratory investigation were collected including immune assays and AQP-4 antibody. Results: There was no statistically significant difference between the groups in terms of brain MRI data at the baseline and outcomes. Between the two groups, there were statistically significant differences in last observer spinal MRI (p=0.025), annual relapse rate before treatment with RTX group (P=0.021), EDSS pretreatment (p=0.005), annual relapse rate post-treatment. When it came to the number of relapses after treatment, there was a high statistically significant difference between the two groups (p=0.016), with group 1 (RTX group) having zero relapses. There was a statistically significant decrease comparing EDDS scores pre-and post-treatment regarding the RTX group (p=0.003). Adverse events were Infusion rate reaction (5.3%) and pneumonic COVID (9.5%) of patients. Conclusion: RTX is more helpful and less harmful for NMO-SD patients than AZA.

16.
International Journal of Pharmaceutical Sciences and Research ; 13(9):3786-3791, 2022.
Article in English | EMBASE | ID: covidwho-2033428

ABSTRACT

Covid-19 associated mucormycosis rose sharply during India’s 2nd wave of coronavirus infections. The administration of immunosuppressive drugs led to increased susceptibility of patients to oppurtunistic diseases like mucormycosis. One of the causative species of mucormycosis is Rhizopus microsporus. For this study, we choose two chalcones and examined their ability to act as potential anti-mucormycosis agents by inhibiting the R. microsporus endo β-1,4-Mannanase protein. We studied their possibility to inhibit the SARSCoV-2 main protease and RNA dependent RNA polymerase. The chalcones were docked against the proteins of interest using Autodock 4.0 followed by Molecular dynamics simulation. Our study revealed that 2’, 4’-dihydroxychalcone had the best docking with the endo β-1,4-Mannanase protein with steady root mean square deviation values and showed favourable docking with the SARS-CoV-2 proteins while passing all the drug likeliness filters. Thus 2’, 4’-dihydroxychalcone can be put through further verification to test its efficacy against the causative agents of mucormycosis and the Covid-19 pandemic.

17.
Vaccines ; 10(8), 2022.
Article in English | EMBASE | ID: covidwho-2033167

ABSTRACT

The term hybrid immunity is used to denote the immunological status of vaccinated individuals with a history of natural infection. Reports of new SARS-CoV-2 variants of concern motivate continuous rethought and renewal of COVID-19 vaccination programs. We used a naturalistic case-control study design to compare the effectiveness of the BNT162b2 mRNA vaccine to hybrid immunity 180 days post-vaccination in prioritized and non-prioritized populations vaccinated before 31 July 2021 in three Swedish counties (total population 1,760,000). Subjects with a positive SARS-CoV-2 test recorded within 6 months before vaccination (n = 36,247;6%) were matched to vaccinated-only controls. In the prioritized population exposed to the SARS-CoV-2 Alpha and Delta variants post-vaccination, the odds ratio (OR) for breakthrough infection was 2.2 (95% CI, 1.6–2.8;p < 0.001) in the vaccinated-only group compared with the hybrid immunity group, while in the later vaccinated non-prioritized population, the OR decreased from 4.3 (95% CI, 2.2–8.6;p < 0.001) during circulation of the Delta variant to 1.9 (95% CI, 1.7–2.1;p < 0.001) with the introduction of the Omicron variant (B.1.617.2). We conclude that hybrid immunity provides gains in protection, but that the benefits are smaller for risk groups and with circulation of the Omicron variant and its sublineages.

18.
Therapeutic Advances in Infectious Disease ; 9, 2022.
Article in English | EMBASE | ID: covidwho-2032594
19.
BMJ Supportive and Palliative Care ; 11:A37, 2021.
Article in English | EMBASE | ID: covidwho-2032472

ABSTRACT

Background St Gemma's Hospice offered an onsite breathlessness group for two years. In late 2019 the content was reviewed, and in January 2020 a reviewed programme was piloted (P1) incorporating self-management strategies for patients experiencing breathlessness, fatigue and anxiety. COVID-19 restrictions led to the move to a video version, (P2) patients watching at home supported with telephone follow up. Aim To provide a comprehensive new programme, enabling education sessions to continue for patients whilst unable to attend in person. This allowed us to explore use of video as an education resource and consider if there were long term benefits for retaining this model of education delivery. Methods Developed the project by pre-programme literature search, previous model evaluation, gap analysis, and model planning. To move the project online scripted and visual resources were developed, recorded sessions on Zoom, uploading to a secure video platform accessed by password. Pre- and post- course patient VAS scores of management of symptoms, feedback from patients and staff, comparison patient numbers for onsite and online sessions and analysis of cost effectiveness. Results P1 = 15 patients Jan 2020 - March 2020. P2 = 72 patients August 2020 and March 2021. Manage symptoms on a VAS of 1-10, 1 = not managing;10 = well managing Breathlessness, mean improvement -1.4 Fatigue, mean improvement - 0.55 Anxiety, mean improvement - 2.4 Positive feedback;ongoing accessibility to toolkit resources, patient self-efficacy Cost;Onsite per patient = £116.31 versus Online Program = £76.30 Conclusions Mean values for pre- and post- evaluations indicate improvement of patients' ability to self-manage except for fatigue which was inconclusive. Consideration is required of patients' suitability, symptoms/technical ability. Offering virtual education sessions widened access for patients who struggled to attend on site due to transport, mobility or high volume oxygen. Video education is as effective as face-to-face.

20.
HemaSphere ; 6:3982, 2022.
Article in English | EMBASE | ID: covidwho-2032174

ABSTRACT

Background: Rituximab is one of the second-line treatments for ITP. At present, there are few studies on low-dose rituximab, lacking of a large number of prospective and randomized trials to support the efficacy and safety of lowdose rituximab, especially in children's ITP. Influenced by COVID-19, we used two low-dose rituximab regimens before and after March 2020 for second-line treatment of children's ITP. Aims: To compare the efficacy and safety of two different regimens for low-dose rituximab of children patients with chronic /refractory ITP, so as to provide basis for clinical treatment. Methods: 83 children patients were enrolled in this study and non-randomly assigned to receive 100mg/200mg (body weight 30kg) rituximab weekly for 4 weeks (group A, 53 cases) or a single dose of 375mg / m2 rituximab (group B, 30cases). The study was follow-up for at least half a year. Results: The baseline data of group A and B were the same. For group A: Overall and complete response (OR and CR) rates were 35.8% and 15%, respectively;the side effects rate is 3.8%. In responders, the median time to response was 4 (1 -12) weeks, with a median follow-up time of 12 (6 ∼ 36) months, 6 of 19 responders (31.6%) relapsed. For group B: OR and CR rates were 36.7% and 23%, respectively;the side effects rate is 10%. In responders, the median time to response was 1 (1 ∼ 4) weeks, with a median follow-up time of 11.5 (6 ∼ 17) months, 4 of 11 responders (36.4%) relapsed. No significant difference in the OR, NR, relapse free survival and incidence of side effects was observed in patients between the two groups. Image: Summary/Conclusion: The two low-dose rituximab regimens in the treatment of ITP in children both are safe and effective;The single-agent scheme is more recommended because of easier use and not increasing safety events.

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